MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29G 12,7MM EMA NON CE; PISTON SYRINGE

Catalog Number 320921

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/10/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a syringe 0.5ml 29g 12,7mm ema non ce had the cannula protruding through the needle shield which caused two needle sticks before use.The following was reported by the initial reporter" "customer pricked himself in store while the packet of insulin syringes was on the shelf.The needle protruded through the orange cap and went into the customers finger.We have escalated the matter to our head office regarding the injury in store.Customer was very upset and dis-chem pharmacy provided assistance to sent the patient/customer for screening for tb, hiv.Preventative anti-retro-viral treatment provided to customer and case escalated to dis-chem pharmacy group head office.On (b)(6) 2020: as part of the complaint, upon visiting the store to pick up sample on (b)(6) 2020, the responsible pharmacist informed that upon checking the pack that pricked the patient, she picked up a different syringe within the same pack which also pricked her as the needle was protruding out the safety cap.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-10-30.H6: investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Bd was able to confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.See h.10.

Event Description

It was reported that a syringe 0.5ml 29g 12,7mm ema non ce had the cannula protruding through the needle shield which caused two needle sticks before use.The following was reported by the initial reporter" "customer pricked himself in store while the packet of insulin syringes was on the shelf.The needle protruded through the orange cap and went into the customers finger.We have escalated the matter to our head office regarding the injury in store.Customer was very upset and dis-chem pharmacy provided assistance to sent the patient/customer for screening for tb, hiv.Preventative anti-retro-viral treatment provided to customer and case escalated to dis-chem pharmacy group head office.(b)(6) 2020 :as part of the complaint, upon visiting the store to pick up sample on (b)(6) 2020, the responsible pharmacist informed that upon checking the pack that pricked the patient, she picked up a different syringe within the same pack which also pricked her as the needle was protruding out the safety cap.".

• Brand Name: SYRINGE 0.5ML 29G 12,7MM EMA NON CE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10816984
• MDR Text Key: 215529771
• Report Number: 1920898-2020-01549
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 320921
• Device Lot Number: 8197658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other